Multi-event May 2019 FDA Recall Drug by Surgery Pharmacy Services Inc

This Multi-event Class II drug recall was voluntarily initiated by Surgery Pharmacy Services Inc on May 30, 2019 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance.. The product was distributed in Distributed in GA, TN and the recall is currently terminated.

Reported Recall Events

D-0610-2020 TERMINATED D-0611-2020 TERMINATED

Recall Number: D-0610-2020

Reason for Recall
Lack of sterility assurance.
Initiated
05-30-2019
Reported
12-18-2019
Quantity
1149 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84401
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Surgery Pharmacy Services Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in GA, TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-04-2021
Product Description About Product Description
Full technical description of the product.
Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.AVE., SUITE F., CHATTANOOGA, TN., 37409,

Batch or Lot Expiration Information

Lot# RX numbers from 311976 to 314888

Recall Number: D-0611-2020

Reason for Recall
Lack of sterility assurance.
Initiated
05-30-2019
Reported
12-18-2019
Quantity
84 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84401
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Surgery Pharmacy Services Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in GA, TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-04-2021
Product Description About Product Description
Full technical description of the product.
Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.AVE. CHATT,TN37409

Batch or Lot Expiration Information

Lot# RX numbers from 311976 to 314888